Bharat Biotech's Covaxin will begin Phase 2 and 3 clinical trials in the age group of 2 to 18 years in June, according to sources at the Hyderabad-based vaccine manufacturer.
Covaxin is being used on adults in India's ongoing Covid-19 vaccination drive, which was created by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). Bharat Biotech was granted permission to conduct a Phase 2/3 clinical trial of Covaxin in children aged 2 to 18 years old earlier this month.
According to Bharat Biotech sources, the Phase 2/3 trials for children will begin in June. The first dose will be given in June and will last until mid-July. According to Bharat Biotech sources, the youngest child recruited for the clinical study is two years old.
The trial will include 525 people at different locations, including the AIIMS in Delhi, the AIIMS in Patna, and the Meditrina Institute of Medical Sciences in Nagpur. The vaccine will be administered intramuscularly in two doses on days 0 and 28 of the trial.
On May 13, the Indian Drugs Controller General approved Bharat Biotech's Covaxin for Phase 2-3 clinical trials on children aged 2 to 18.
Following a thorough review, the DCGI approved the Subject Expert Committee's (SEC) recommendation on Covid-19 and granted permission to perform a phase 2-3 clinical trial of Covaxin in children aged 2 to 18 years.
Bharat Biotech, based in Hyderabad, had previously suggested conducting phase 2-3 clinical trials of Covaxin in children aged 2 to 18. The Covaxin shot will be administered intramuscularly in two doses over the course of 28 days in the study.
The proposal was discussed in the Subject Expert Committee (SEC) at the Covid-19 meeting on May 11 as a fast regulatory response.
Following extensive deliberation, the committee recommended that permission be granted to perform a planned phase 2/3 clinical trial under certain conditions.
On February 24, the plan was discussed at an SEC conference, and the company was asked to request a revised clinical trial protocol.
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